GVP Module VI: Management and Reporting of Adverse Reactions to Medicinal Products




If you’re looking to get to grips with the regulations and guidelines for the collection and reporting of adverse events, this course will provide you with a good introduction and equip you with the fundamental principles of Pharmacovigilance.

The course is written by Pharmacovigilance professionals working in the pharmaceutical industry and has been reviewed by expert peers prior to release.  We are pleased to be able to offer you training that you can complete when and where is most convenient for you.

This course provides a comprehensive overview of Module VI (Management and reporting of adverse reactions to medicinal products) of the Guideline on Good Pharmacovigilance Practices released by the European Medicines Agency in June 2012.

This course is primarily aimed at individuals who are either new to Pharmacovigilance or who work in departments within the pharmaceutical industry that work closely with drug safety e.g. all Medical Information professionals. It is also an ideal course for those providing medical review and for  PV professionals with a number of years of experience, but who would like a refresher and/or require evidence  of their training on, and understanding of, the GVP Modules.

Accessing this course will enable delegates to:

  • Learn the key definitions and industry terms
  • Find out more about the European regulations and guidelines
  • Understand what adverse events are and how they are collected
  • Learn how to identify an adverse event
  • Know what information to collect for an adverse event report
  • Learn the reporting timeframes

Links are provided to other important sources of information.

The course includes a test of understanding to obtain a formal certificate as evidence of training.

 Target audience:

New PV professionals.

Individuals in departments that work closely with PV

Those providing medical review

PV professionals with a number of years of experience, but who require refresher and/or evidence of training on GVP Module VI

 Time: 1 -2 hours

Level of difficulty: Introductory / intermediate

Booking and payment

PIPA members:  Payment can be made online at point of booking which gives you immediate access to the course. If you require PIPA to send you an invoice, then please note that the course will only be activated once payment of the invoice has been confirmed.

Non-members:  As a not-for-profit association, PIPA can only make this course available to members. However, non-members may easily access the course by taking out a month membership for a £25.00 supplement.  The course must be completed within the duration of the month membership as we are unable to provide a course extension. You can apply for membership here. Please note that our month membership option only offers access to one online course and both the membership and course fees must be paid for online at time of booking.  We do not offer an invoice option for this booking combination.